Back to resultsA Pilot Clinical Evaluation of Astepro® Nasal Spray for Management of Early SARS-CoV-2 Infection (COVID-19)
Primary Purpose
COVID-19
Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Experimental: Primary Cohort
Placebo Comparator: Primary Cohort - Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for COVID-19
Eligibility Criteria
Inclusion Criteria: • 18 and up Ability to consent Have a Covid-19 positive saliva sample prior to the start of treatment; or positive rapid antigen test at home confirmed via first COVID-19 positive saliva sample Ability to follow the study instructions and adhere to the study procedures Ability to provide every other day saliva samples throughout the study period 10 days, and report symptoms Willing to abstain from any other COVID specific treatment during the duration of the study period. Subjects that have been vaccinated for Covid-19 Does not have any symptoms or only experiencing mild symptoms of Covid-19 (e.g., such as fever below a threshold or no fever, or without severe cough, among others). Inclusion Criteria (Close Contacts): Ability to consent Ability to follow the study instructions and report side effects Ability to provide saliva samples throughout the study period Subjects that have been vaccinated for Covid-19. Exclusion Criteria (Primary Cohort): Women who are breastfeeding, pregnant, or who plan to become pregnant Contradictions to intranasal azelastine (known hypersensitivity) Use of other Covid-19 treatments (steroids, convalescent plasma, therapeutic antibodies, etc.) Intranasal, corticosteroid, immunomodulator, or other medication use which can change the effect of Astepro. Prior Covid infection greater than 5 and less than 30 days before enrollment Subjects who have been involved with any other research study within the last 30 days. A prior hypersensitivity to olopatadine (Patanase), diphenhydramine, hydroxyzine. Subjects that have not been vaccinated for Covid-19. Subjects that have moderate to severe COVID-19 symptoms, or signs of meeting indications (e.g. Shortness of Breath, chest pains) for urgent or emergent therapy (these subjects will be advised to seek emergency medical assistance). Exclusion Criteria (Close Contacts) Prior Covid infection less than 30 days or greater 5 days prior to enrollment in study Use of other Covid-19 treatments Having a positive rapid home or PCR COVID test prior to the positive test for the primary cohort subject they're associated with Involved with any other research study within the last 30 days Subjects that have not been vaccinated for Covid-19.
Sites / Locations
- University of Chicago
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Placebo Comparator
Arm Label
Primary Cohort - Azelastine
Primary Cohort - Placebo
Arm Description
This is a double-blind clinical trial. All subjects will be sent an instructional video and be given written instructions which will educate them on how to use the drug or placebo nasal spray. Patients will follow the dosing instructions for Astepro® 0.15% nasal spray.
This is a double-blind clinical trial. A Placebo will be provided by Bayer which features similar color and packaging. Both groups will also undergo recommendations for supportive care, which will be standardized. Any patients who develop severe disease will be given instructions for escalation of care.
Outcomes
Primary Outcome Measures
Astepro for use in managing Covid-19 symptoms and assessing viral load in participants..
The primary cohort will be followed while utilizing study drug or placebo to evaluate the outcomes and saliva collection to follow viral load.
Secondary Outcome Measures
Rate of Covid-19 infectivity in primary cohorts close contacts
Saliva will be collected from close contacts to assess any changes in Covid-19 infectivity.
Change from baseline in upper respiratory symptoms and Quality of Life, as measured by the WURSS44 survey
WURSS44 is illness-specific quality of life instrument, designed to assess the negative impact of viral acute upper respiratory infection.
Change from baseline symptoms and quality of life utilizing the All of Us Research Program Covid-19 Participant Experience (COPE) survey
All of Us Research Program Covid-19 Participant Experience (COPE) survey is utilized to assess the health impact of Covid-19.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06008860
Brief Title
A Pilot Clinical Evaluation of Astepro® Nasal Spray for Management of Early SARS-CoV-2 Infection
Acronym
COVID-19
Official Title
A Pilot Clinical Evaluation of Astepro® Nasal Spray for Management of Early SARS-CoV-2 Infection
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study team proposes to evaluate the efficacy of Astepro® 0.15% nasal spray in treating SARS-CoV-2 infection in adults through a pilot and feasibility clinical trial at the University of Chicago.
Detailed Description
In this study, the study team aims to re-confirm the utility of this medication for use in Covid-19 to decrease the significant impact on quality of life, symptoms, infectivity, and occupation. plan to recruit vaccinated adults immediately upon Covid-19 diagnosis at one major Chicago University and follow viral load as a primary outcome in those randomized to receive Astepro® vs. placebo. Subjects who have a home antigen test or polymerase chain reaction (PCR) positive diagnosis of Covid-19 will be enrolled in the study. Viral load will be assessed at Day -1, day of presentation, followed by self-collected saliva over the subsequent 10 days in patients getting either azelastine or placebo.
Specific Aims
To address this hypothesis, the study team is investigating the following specific aims:
Compare the trajectories of SARS-CoV-2 viral load in the upper airway of adults with new onset Covid-19 randomized to receive azelastine at standard rhinitis dosing (n=70) or placebo (n=70) over 10 days. The study team will target early disease (immediately upon diagnosis), mild severity in outpatients (facilitating study participation and self-sample collection), and pragmatic, receptive target populations (volunteers living nearby).
Determine if there is a decrease in R0 in Covid-19 positive patients and their closest contacts The study team hypothesizes that less new covid infections will be observed among close contacts who co-habitate with subjects randomized to the Astepro (azelastine) arm.
Determine whether treatment with azelastine improves pertinent clinical parameters in these subjects. Rates, durations, and intensities of key symptoms will be captured using existing, low burden data collection instruments that meet FDA guidelines. All sample and data collection, including validated, objective olfactory testing, will be contactless, minimizing risk.
Assess and quantitate side effects, subject satisfaction, and tolerability of azelastine in this setting. Given the heterogeneous nature of Covid-19, the study team will assess the feasibility of this treatment from the patient standpoint, including qualitative and quantitative feedback, to inform future trials and scaling.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
All subjects will be sent an instructional video and be given written instructions which will educate them on how to use the drug or placebo nasal spray. Patients will follow the dosing instructions for Astepro® 0.15% nasal spray.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
This is a double-blind clinical trial. Randomization schedules will be generated and stratified by age (18-30, 31--40, 41-50, and ≥50 years) and sex, using computer-generated random numbers and alternating block sizes. Only the study statistician will have access to the randomization lists. The assigned treatment for each study subject will be obtained via REDCap. The Investigational Drug Service (IDS) pharmacy will be used to distribute the drug or placebo as provided by Bayer. The pharmacy will also help to coordinate and track randomization.
Allocation
Randomized
Enrollment
280 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Primary Cohort - Azelastine
Arm Type
Other
Arm Description
This is a double-blind clinical trial. All subjects will be sent an instructional video and be given written instructions which will educate them on how to use the drug or placebo nasal spray. Patients will follow the dosing instructions for Astepro® 0.15% nasal spray.
Arm Title
Primary Cohort - Placebo
Arm Type
Placebo Comparator
Arm Description
This is a double-blind clinical trial. A Placebo will be provided by Bayer which features similar color and packaging. Both groups will also undergo recommendations for supportive care, which will be standardized. Any patients who develop severe disease will be given instructions for escalation of care.
Intervention Type
Drug
Intervention Name(s)
Experimental: Primary Cohort
Other Intervention Name(s)
azelastine
Intervention Description
Astepro (azelastine) is a second generation antihistamine, as well as an anti-inflammatory and mast cell stabilizer8. It is available as a 0.1% and 0.15% nasal spray by prescription in the USA and over-the-counter in the European Union (EU). Dosing for adults and adolescents 12 years and older is 1 or 2 sprays per nostril twice daily (0.1%) or 2 sprays per nostril once daily (0.15%)9. It is approved by the FDA for treatment of seasonal allergic rhinitis symptoms (rhinorrhea, sneezing, and nasal pruritus) in adults and children 2 years and older, perennial allergic rhinitis in adults and children ages 6 months and older, and the symptoms of vasomotor rhinitis (rhinorrhea, nasal congestion and postnasal drip) in adults and adolescents 12 years and older9.
Intervention Type
Other
Intervention Name(s)
Placebo Comparator: Primary Cohort - Placebo
Intervention Description
A Placebo will be provided by Bayer which features similar color and packaging as azelastine.
Primary Outcome Measure Information:
Title
Astepro for use in managing Covid-19 symptoms and assessing viral load in participants..
Description
The primary cohort will be followed while utilizing study drug or placebo to evaluate the outcomes and saliva collection to follow viral load.
Time Frame
Baseline (Day -1) through Day 10
Secondary Outcome Measure Information:
Title
Rate of Covid-19 infectivity in primary cohorts close contacts
Description
Saliva will be collected from close contacts to assess any changes in Covid-19 infectivity.
Time Frame
Day 1, Day 11
Title
Change from baseline in upper respiratory symptoms and Quality of Life, as measured by the WURSS44 survey
Description
WURSS44 is illness-specific quality of life instrument, designed to assess the negative impact of viral acute upper respiratory infection.
Time Frame
Primary Cohort: Baseline (Day -1) through Day 10, Close Contact Cohort: Day 1 and Day 11
Title
Change from baseline symptoms and quality of life utilizing the All of Us Research Program Covid-19 Participant Experience (COPE) survey
Description
All of Us Research Program Covid-19 Participant Experience (COPE) survey is utilized to assess the health impact of Covid-19.
Time Frame
Primary Cohort: Baseline (Day -1) through Day 10, Close Contact Cohort: Day 1 and Day 11
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
• 18 and up
Ability to consent
Have a Covid-19 positive saliva sample prior to the start of treatment; or positive rapid antigen test at home confirmed via first COVID-19 positive saliva sample
Ability to follow the study instructions and adhere to the study procedures
Ability to provide every other day saliva samples throughout the study period 10 days, and report symptoms
Willing to abstain from any other COVID specific treatment during the duration of the study period.
Subjects that have been vaccinated for Covid-19
Does not have any symptoms or only experiencing mild symptoms of Covid-19 (e.g., such as fever below a threshold or no fever, or without severe cough, among others).
Inclusion Criteria (Close Contacts):
Ability to consent
Ability to follow the study instructions and report side effects
Ability to provide saliva samples throughout the study period
Subjects that have been vaccinated for Covid-19.
Exclusion Criteria (Primary Cohort):
Women who are breastfeeding, pregnant, or who plan to become pregnant
Contradictions to intranasal azelastine (known hypersensitivity)
Use of other Covid-19 treatments (steroids, convalescent plasma, therapeutic antibodies, etc.)
Intranasal, corticosteroid, immunomodulator, or other medication use which can change the effect of Astepro.
Prior Covid infection greater than 5 and less than 30 days before enrollment
Subjects who have been involved with any other research study within the last 30 days.
A prior hypersensitivity to olopatadine (Patanase), diphenhydramine, hydroxyzine.
Subjects that have not been vaccinated for Covid-19. Subjects that have moderate to severe COVID-19 symptoms, or signs of meeting indications (e.g.
Shortness of Breath, chest pains) for urgent or emergent therapy (these subjects will be advised to seek emergency medical assistance).
Exclusion Criteria (Close Contacts)
Prior Covid infection less than 30 days or greater 5 days prior to enrollment in study
Use of other Covid-19 treatments
Having a positive rapid home or PCR COVID test prior to the positive test for the primary cohort subject they're associated with
Involved with any other research study within the last 30 days
Subjects that have not been vaccinated for Covid-19.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brandon Baird
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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A Pilot Clinical Evaluation of Astepro® Nasal Spray for Management of Early SARS-CoV-2 Infection
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